Recalling Firm
Town and Country Compounding and Consultation Services
PM Resources, Inc. dba Virbac Animal Health, Inc.
American Red Cross Blood Services Tennessee Valley Region
Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables
Northern California Community Blood Bank
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Stryker Instruments Div. of Stryker Corporation
Philips Electronics North America Corporation
Lifesouth Community Blood Centers - Montgomery Region
American National Red Cross (The), Lewis and Clark Region
Fairway Group Holding Corp dba Fairway Bakery LLC
American Red Cross Blood Svs. Indiana-Ohio Region
American National Red Cross, Penn Jersey Region

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
CA, FL, ID, IL, LA, MI, MN, NC, ND, NJ, NY, OH, PA, SC, VT and Puerto Rico
CA, FL, ID, IL, LA, MI, NC, NJ, NY, OH, PA, VT, and Puerto Rico
No international firms. Wholesalers in the following states: SC, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, ND, MT, IL, MO, NE, LA, AR, TX, CO, NM,
USA: All states in USA including PR except AK, HI, WV, DE & RI.
Nationwide in US: AL, AZ, CA , CO, FL, GA, LA, MI, ND, OH, SC, TN, UT, VA
U.S. food distributors located in CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, NE, NJ, NY, OH, OK, PA, TN, TX, UT, WA and WI.
AL, AR, DC, DE, FL, GA, IA, IL, KY, KS, LA, MD, MI, MO, MS, NC, OH, OK, PA, SC, TN, TX, VA, WI and WV.
Nationwide, Puerto Rico, United Arab Emirates, Australia, Bahrain, Canada, Germany, Denmark, UK, Honduras, Ireland, Mexico, Malaysia, Netherlands, Portugal, Saudi Arabia, Singapore, and El Salvador.
Nationwide. Outside the US to include: Australia, Mexico and United Arab Emirates.
US Nationwide. The product was shipped to the following states: GA, IL, NC, NY, and TX.
AL, AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, KS, LA, MD, ME, MI, MN, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA and Puerto Rico Asturias, Australia, Chile, Greece, Hong Kong, India, Indonesia, Iraq, Japan, Kuwait, Malaysia, Mexico, Nigeria, Qatar, Russia, Slovenia, Spain, Syria, Trinidad, Turkey, UAE, UK, and Vietnam
CA, FL, GA, IA, IN, MN, MO, OR, PA, TN, TX, WI and Puerto Rico
US nationwide. The product was distributed to the followin states: CA, CO, FL, ID, IN, KY, LA, MA, MI, MN, MO, NE, NJ, NM, OH, PA, SC, TN, and TX. The product was also distributed in Puerto Rico.
Worldwide Distribution - US (Nationwide) Foreign: Austria Belgium Bulgaria Brazil Chile Cyprus Denmark Egypt Finland France France Germany Greece Hungary Iran Ireland Israel Italy Japan Kenya Kuwait Latvia Luxembourg Mexico Namibia Netherlands Nigeria Norway Poland Portugal Romania Saudi Arabia Serbia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom
US nationwide. The products were shipped to three government facilities. The products were distributed to the following states: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA SC, TN, TX, UT, VA, VT, and WI.
Nationwide Distribution to AL, AR, CA, FL, GA, IL, KY, LA, MI, MN, MO, NC, OH, OK, SC, NY, ME, PA, MD, VA, WA, WI, WV, TN, and TX
US: Nationwide (CA, TX, KY, FL, IL,PA,OH, GA, NJ, NC, KS,AR, CO, NE, NY, VA, AZ, OK). OUS: Germany
Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
IA, MD, NY, WA Foreign: France, Germany, The Netherlands, Hungary, Singapore
Select Whole Foods Market stores in Pennsylvania, Maryland, Ohio, Kentucky, New Jersey, Virginia and Washington D.C.
Distributed in the state of Pennslyvania.
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico, and to the countries of : Bermuda, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.
Washington, Oregon, Idaho, Montana, Nebraska, Military commissaries
CA, CO, NY, WA Foreign: Austria, Bolivia, Bosnia , Sweden, Norway, Netherlands, Japan, Great Britain,
Worldwide Distribution - US including FL and MA. Internationally to Canada
US Distribution to the states of : PA, FL, NJ, IL and MA.
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MD, ME, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TN, VA, WA and WI., and to the countries of : Austria, Australia, Canada, Germany, France, Spain, India, Switzerland, Italy, South Korea, United Kingdom, Brazil, Luxembourg, Greece, Guatemala, Netherlands, South Africa, and Sweden
Foreign Distribution in the Italy, France, Switzerland, Germany, Sweden
Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland.
Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
Nationwide in US & Worldwide: CA, AU, GB, ES, FR, AE, AT, BE, BG, CH, CL, CY, CZ, DE, DK, DO, FI, GI, GR, HR, HU, IE, IL, IT, JP, LT, LV, MT, MX, MY, NG, NL, NO, NZ, PH, PL, RE, RO, RU, SE, SG, SI, SK, TH, TR
Nationwide Distribution to CA, CO, FL, GA, IL, KS, KY, MA, MO, MS, NC, NJ, NY, OH, OK, OR, PA and TX.
Worldwide Distribution - US including CA, NJ, MD, TX, FL, NC, MO, and Puerto Rico. Internationally to AUSTRIA, BOLIVIA, CANADA, CHILE, CYPRUS, NETHERLANS, EGYPT, GERMANY, HONG KONG, ISRAEL, ITALY, SWITZERLAND, and VIETNAM
Worldwide Distribution - US (nationwide) Internationally to AU, CA, CL, CH, ES, FR, GB, SE, JP, FR, ZA, and NL.
U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.
Worldwide Distribution-US (nationwide) in states of: AK, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, LA, MN, ND, NV, NY, SD, TN, TX, WI, WY and countries of: Canada, Chile, Croatia, Germany, Greece, Hungary, Iran, Italy, Latvia, Lebanon, Poland, Portugal, Romania, Spain, Tanzania, and United Kingdom.
Worldwide Distribution-US (nationwide)and the following countries: Afghanistan, Albania, Algeria, Argentina, Aruba, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg, Brazil, British Guyana, Bulgaria, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Dominican Rep., Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Great Britain, Grenada, Guatemala, Honduras, Hungary, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kazakhstan, Kosovo, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Spain, South Africa, South Korea, Suriname, Switzerland, Syria, Taiwan, Tadjikistan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Turkmenistan, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, and Vietnam.
Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI and countries of: Canada, Japan, Venlo (Netherlands), France, and UK (United Kingdom).
United States, United Arab Emirates, and Colombia
Product distributed in NC and nationwide through the internet.
Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.
Worldwide Distribution -US including CA, NY and Internationally to United Kingdom, Australia, Norway, and Thailand
US Distribution to the states of : GA. MI, OK, SC, TX, VA
US Distribution to the states of : FL, GA. IL, MO, TX
Nationwide Distribution to AL, AZ, AR, CA, CO, FL, GA, IA, KS, KY, LA, MA, MI, MN, MO, NV, NJ, NC, SC, TN, TX, VA, WA, WV, WI and Puerto Rico
Nationwide Distribution to IN, LA, and TX
Worldwide Distribution - USA (nationwide) Distribution including BB(Barbados) and PR (Puerto Rico) and to the states of : AK, AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY., and to the countries of: China, Europe, Hong Kong, India, Korea, Mexico, New Zealand, Panama, Singapore, and Taiwan. 480 US customers and 3 US distributors. Product was also shipped to 10 ex-US regions. 15 US government sites received affected product
Worldwide Distribution - US including CA. MN, OK. FL. MO, TN, KS, TX, AZ, MS, IA, MA. NC, NY. IN, NJ, VA. LA, WA, WI, PA. CT, G,. MT, MD, LA., WV, OH, and DC. Foreign distribution to Taiwan, Japan, Korea, Turkey. Malaysia, Vietnam, Greece, China, Spain, France, Italy, Pakistan, and Georgia,
Nationwide Distribution to OH, NE, FL, LA, NY, TX, MS, MD, CT, AL, PA
New York, New Jersey and Connecticut and via the internet
Nationwide, China, Germany, Norway, UK, Canada, Ireland, Italy, Australia, New Zealand, Hong Kong, Croatia
Distribution was made to medical facilities in CA, CO, CT, MA, MD, MN, MT, NE, NV, NY NJ, PA, SC, WA, and WI. Foreign distribution was made to Canada, as well as other countries.
Distributed in Idaho, Maryland, Nevada, Oregon, and Washington
United States and Puerto Rico No foreign distribution.

Product Description
Rx CHOICE brand LIQUID VITAMIN C, 16 FL OZ (473 mL), NDC 50383-167-16 --- HI-TECH PHARMACAL CO., INC. Amityville, NY 11701
II Glucose, For Veterinary in Vitro Diagnostic Use, 25 strips.
II EZ Health Check Vet Multistrip [Panel-V], For Veterinary in Vitro Diagnostic Use, 25 strips.
4 GL PAIL SFF FRUIT MIX N/O - Light Syrup, UPC 4294710455
4 GL PAIL SFF CANTALOUPE CHUNKS, UPC 4294710419; 4/1 GL Case Cantaloupe Chunks UPC 4294740119
1 GL CVF CANTALOUPE CHUNKS - LS, UPC 50758108449775;
1 GL CVF FRUIT SALAD DELUXE IN GRAPE JUICE, UPC 50758108455745
1 GAL PAIL SYSCO IMP. TROPICAL SALAD - LS, UPC 7486563429
1 GL JAR SFF CANTALOUPE CHUNKS - Light Syrup, UPC 4294700119
**1) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #5075810 8449874; **2) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC #50758108449904; **3) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874 ; **4) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874 ; **5) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449904; **6) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449898 ; **7) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449898 ; **8) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449904 ; **9) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874 ; **10) 1 GL CVF FRUIT SALAD DELUXE - LS, UPC 50758108449874 **11) 1 GL CVF FR.UIT SALAD DELUXE - LS, UPC 758108563858
1 GL PAIL and 2x1 GL/case SFF FRUIT MIX IN GRAPE JUICE, UPC 4294717155
2/1 GL SYSCO IMP. FRUIT MIX -LS, UPC 10074865081938;
2/1 GL SFF TROPICAL MIX IN GRAPE JUICE, UPC 4294727161
1 GL PAIL SYSCO CANTALOUPE CHUNKS - LS, UPC 7486548718
2 GL, 1 GL PAIL SFF CANT/CHUNKS GRAPE JUICE, UPC 4294717119
4 GL PAIL SFF FRUIT MIX - Light Syrup, UPC 4294710455
4/1 GL SYSCO FRUIT MIX GRAPE JUICE, UPC 10074865624296
4/1 GL SYSCO IMP FRUIT MIX, UPC 10074865435236
2 GL PAIL SYSCO IMP. FRUIT MIX W/GRAPE JUICE, UPC 7486563430
4 GL PAIL FRUIT MIX-SMALL CUT, UPC 4294710455
1 GL PAIL SYSCO IMP. CANTALOUPE/GRAPE JUICE, UPC 7486562450
1 GL PAIL SYSCO FRUIT MIX - LS, UPC 47486540223
3 GL PAIL SFF SEASONAL FRUIT MIX B, UPC 4294710277
1 GL PAIL SYSCO FRUIT MIX - LS, UPC 7486540223; 4 GL Pail UPC 7486572788
3rd DEGREE capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
BLACK GOLD X ADVANCED capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
BLACK LABEL X capsules, 60-count bottles, Manufactured for: Making it A Lifestyle, L.L.C.
. Product was packaged into 5 & 40 lb boxes.
C-PAV/PHENTOL/ATROP/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
C-PAV/PHENTOL/PGE1, All strengths, All sizes, Rx only, Colonia Care Pharmacy, Colonia NJ 07067
Fresh Express Kit Caesar salad, Net Wt. 7.6 oz. (215g), Fresh Express Incorporated, 550 S. Caldwell St. Charlotte, NC 28202, packed in clear flexible plastic bags. Product Code: G163B13A
raw frozen ground spent hen. Product is sold in 50 lbs block.
Raw frozen mixed feed containing ground spent hen. Product is sold in 50 lbs. block or 1000# totes
Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
COMFORT SHIELD (dimethicone) Barrier Cream Cloths, 3%, packaged as impregnated cloths wrapped in flexible packaging, further packed into inner cartons, with the inner cartons are placed into an over shipper sold in a) 3-count disposable barrier cloths per package, 45 packages per carton, 2 cartons (90 packages) per case, Reorder # 7503, NDC 53462-915-50; b) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7905, NDC 53462-915-80; c) 3-count disposable barrier cloths per package, 50 packages per carton, 2 cartons (100 packages) per case, Reorder # 7502, NDC 53462-915-51; d) 8-count disposable barrier cloths per package, 24 packages per carton, 2 cartons (48 packages) per case, Reorder # 7508, NDC 53462-915-81; e) 24-count disposable barrier cloths per tub, 12 packages per case, Reorder # 7524, NDC 53462-915-60; f) 24-count disposable barrier cloths per package, 9 packages per carton, 2 cartons (18 packages) per case, Reorder # 7526, NDC 53462-0915-62; Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013.
2% Chlorhexidine Gluconate* Cloth, 2 disposable cloths per package, further packaged into 96 packages per case, labeled as a) Reorder #9705, b) Reorder #9701-P, and c) Reorder #9780, Sage Products LLC 3909 Three Oaks Road, Cary, Illinois 60013, NDC 53462-705-20.
Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 fl. oz. (946 ml.), Sperian Eye & Face Protection, Inc. (a Honeywell Company), Platteville, WI 53818
Cardinal Health Shampoo Cap Fragrance Free. 1 unit per package, 30 packages per case.
Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Single-dose Preservative-Free vials, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1159-02
Sermorelin/GHRP-6 Injection 6 mg-3 mg Lyophylized I, 2 mL vial, Rx, Town and Country Compounding and Consultation Services, Ridgewood, NJ 074502
Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blisters containing 10 tablets each, Rx only, Manufactured by: Watson Pharma Private Ltd., Verna, Salcette Goa INDIA, Distributed by: Impax Generics, Hayward, CA
Ultroid Procedure Pack including the Ultroid Sterile Disposable Probes.
Ultroid Hemorrhoid Management Systems 110/220 VAC and procedures kit including the Ultroid Disposable Sterile Probes
Ultroid Mobile Generator/Battery operated unit including the Ultroid Sterile Disposable Probes
Ultroid Sterile Disposable Probes sold individually
RILEXINE (cephalexin) Chewable Tablets 600 mg, 100 tablets, NDC 051311-046-10, NADA # 141-326, Virbac ANIMAL HEALTH label, Rx only --- Mfd. for: Virbac AH, Inc. Fort Worth, TX 76137
RILEXINE (cephalexin) Chewable Tablets 300 mg, 100 Tablets, NDC 051311-036-10, NADA # 141326, Virbac ANIMAL HEALTH label, Rx only --- Mfd. for: Virbac AH, Inc. Fort Worth, TX 76137
RILEXINE (cephalexin) Chewable Tablets 150 mg, 100 Tablets, NDC 051311-026-10, NADA # 141-326, Virbac ANIMAL HEALTH label, Rx only --- Mfd. for Virbac AH, Inc. Fort Worth, TX 76137.
OptiVet Eye Irrigating Solution with Sodium Hyaluronate, 0.1% per 14.78 mL bottle for animal use only, NDC # 51031-011-15
Hy-Optic Eye Irrigating Solution, Sodium Hyaluronate packaged in 14.78 mL bottles, NDC # 51031-011-15
Optimend 0.2% Sodium Hyaluronate Gel Drops for Corneal Repair, packaged in 10 mL bottle gel drops for animal use only, NDC # 51031-013-10
GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15
Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-307-10.
Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-308-10.
Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC., Nashville, TN 37217, NDC 76439-309-10.
Benton's Peanut Butter filled Cookies covered in Rich Fudge, NET WT 9.5 OZ (269 g), UPC 041 498 1896 55, Distributed by ALDI INC. Great Value, Fudge Covered Peanut Butter, 269 g, Imported for Wal-Mart Canada Corp, Product of USA, UPC 6 28915 24342 0.
Girl Scout Peanut Butter Sandwich, NET WT 8 0Z (227 g). UPC 0 20200 07007 8, ABC Bakers/Interbake Foods LLC, Richmond, VA 23233.
24CT Oatmeal Raisin Cookies Net Wt. 24oz UPC 208710004190
12 pack Gourmet Salted Caramel Chocolate Chunk Cookies - Net Wt.15 oz. UPC 2897850203992 ;UPC 289785003998
Kid's Rainbow Sprinkled Cookie Platter 4 lb 14 oz UPC 269935316994
12PK Gourmet Variety Pack Cookies 15 Oz.. UPC 289786203991 24 pack Variety Cookies Net Wt. 24 oz. UPC 208726004191
24CT Take&Bake Oatmeal Rasin Cookies Net Wt. 24oz UPC 20873004194
24CT Double Chocolate Cookies Net Wt. 24oz UPC 208722004195
24CT Take&Bake Sugar Cookies Net Wt. 24oz UPC 208906004195
24CT Candy Cookies Net Wt. 24oz UPC 208713004197
24CT Take&Bake Party Candy Cookies Net Wt. 24oz UPC 208902004199
Dipped Chocolate Chip Cookies Net Wt. 24 oz UPC 269954004995
24CT Chocolate Chip Cookies Net Wt. 24oz UPC 208707004198
24CT Sugar Cookies Net Wt. 24oz UPC 208719004191
24CT Peanut Butter Cookies Net Wt. 24oz UPC 208716004194
Gourmet Chocolate Dipped Cookies Net Wt. 46 oz UPC 269969414994
24CT Take&Bake Chocolate Chip Cookies Net Wt. 24oz UPC 208727004190
12 pack Gourmet Oatmeal Raisin Cookies Net Wt 15 oz. UPC 289784203993 24 pack Gourmet Oatmeal Raisin Cookies Net Wt. 30 oz. UPC 289774706992 Gourmet Oatmeal/Raisin Cookies Net Wt. 30 oz UPC 289771006996
24 pack Gourmet Red Velvet Cookies Net WT. 30 oz. UPC 28977400000
12 pack Gourmet White Choc Chunk Macadamia Cookies Net Wt. 15 oz UPC 289783203994 Gourmet White Chocolate Macadamia Nut Cookies Net Wt. 30 oz. UPC 289770006997
12 Gourmet Variety Pack Cookies - Net Wt. 15 oz UPC 289786003997 Gourmet Variety Pack Cookies Net Wt. 30 oz UPC 289772006995
Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only
Rumensin 1200GM Loose 50#; 50 pound poly woven bags. Product code: 11005 Type B Medicated Feed. Important - must be mixed thoroughly into feed before use. This medicated feed is designed to be fed to dairy cattle. Active ingredient: Monensin (as monensin Sodium) 1200 g/ton
Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Brownwood Farms Yankee Bourbon BBQ Sauce. 19oz glass bottles and 1 gallon
Brownwood Farms Peach Salsa. 17oz glass bottles. Private labels: Bowers Harbor Vineyard (Peach Salsa 12oz). Crossroads.
Brownwood Farms Apple Riesling Salsa. 21oz glass bottles and 1 gallon. Private labels: Arbor Day Farm (Apple Riesling Salsa 21oz). Kimmel Orchard & Vineyard (Apple Riesling Salsa 21oz). St. Julian Winery (Apple Riesling Salsa 19oz).
Brownwood Farms Cherry BBQ Sauce. 21oz glass bottles, 1 gallon, 5 gallon. Private labels: Arbor Day Farm (Cherry BBQ Sauce). Bowers Harbor Vineyard (Cherry BBQ Sauce 12oz). Benjamin Twiggs (Northwoods Cherry BBQ Sauce 16oz). Crossroads. Friske Orchards. Kimmel Orchard & Vineyard (Cherry BBQ Sauce 21oz). Six Lugs. Spirit Valley. Westborn's cherished (Cherry barbecue sauce 21oz).
Brownwood Farms Jalapeno Cherry Salsa. 21oz glass bottles and 1 gallon. Private labels: Arbor Day Farm (Cherry Jalapeno Salsa 21oz). Kimmel Orchard & Vineyard.
Brownwood Farms Jalapeno Cherry Butter. 12oz glass bottles and 1 gallon.
Brownwood Farms BBQ Mustard Glaze. 11oz glass bottles and 1 gallon. Private labels: Kimmel Orchard & Vineyard (Barbeque Mustard 11oz)
CESAR Classics Filet Mignon Flavor, 100 g (3.5 oz) in plastic trays, 24 or 30 trays/case
Ben & Jerrys Brownie Batter Core Ice Cream One Pint (473 mL). Case UPC- 10076840529879 Consumer UPC - 7684052987 Paper carton 8 units per shrink-wrapped case Frozen
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO B PG, Item Number H787065970465, Catalog No.REF 06597046, 2) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T ECHO S PG, Item Number H787065970485, Catalog No. REF 06597048 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970515, Catalog No.REF 06597051, 2) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970535, Catalog No.REF 06597053, 3) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970555, Catalog No.REF 06597055 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO B PG, Item Number H787065970505, Catalog No.REF 06597050, 2) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO S PG, Item Number H787065970525, Catalog No.REF 06597052, 3) 4 F Stiffened Micro-Introducer Kit, 45CM NT/T ECHO A PG, Item Number H787065970545, Catalog No.REF 06597054 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO B PG, Item Number H787065970685, Catalog No.REF 06597068, 2) 1) 5 F Stiffened Micro-Introducer Kit, 45CM NT/T NON-ECHO S PG, Item Number H787065970705, Catalog No.REF 06597070 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
ANGIODYNAMICS 4F Stiffened Micro-Introducer, Item Number H787065971035, Catalog No.REF 06597103 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 5 F Stiffened Micro-Introducer Kit, 45CM SS/SS ECHO B PG, Item Number H787065970395, Catalog No.REF 06597039, 2) 5 F Stiffened Micro-Introducer Kit, STF 5F M.I. KIT 45CM SS/SS ECHO S PG, Item Number H787065970415, Catalog No. REF 06597041 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
ANGIODYNAMICS Percutaneous Introducer Set under the following labels: 1) 4 F Stiffened Micro-Introducer Kit, 45CM SS/T NON-ECHO S PG, Item Number H787065970655, Catalog No.REF 06597065, 2) 4 F Stiffened Micro-Introducer Kit, STF 4F M.I. KIT 45CM NT/T NON-ECHO S PG, Item Number H787065970695, Catalog No.REF 06597069 Indicated for percutaneous introduction of guidewire or catheter into the vascular system following a small 21-gauge needle stick
Darwin's Natural Selections brand, frozen, raw Turkey with Organic Vegetable Meals for Dogs, 2 lbs. packages
ZooLogics brand, frozen, raw Turkey with Vegetable Meals for Dogs, 2 lbs. packages.
Darwin's Natural Selections brand, frozen, raw Beef with Organic Vegetables Meals for Dogs, 2 lbs. packages
Algovita Spinal Cord Stimulation System, Percutaneous Leads, 8-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Leads, 12-Electrode Percutaneous Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 8-electrode Lead Kit; Algovita Spinal Cord Stimulation System Percutaneous Trial Leads, 12-electrode Lead Kit. Model Number (s) 112x-xx (CT), 108x-xx(T). These are part of the Algovita Spinal Cord Stimulation System. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patients spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patients brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patients use of the system.
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) Product Usage: The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer
Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle
LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
LMA MADett, Endotracheal tube Mucosal Atomization Device, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes
PerkinElmer 20ul Clear RoboRack Tip, Pipette (Qty 960) Item Number: 6000677. Used with the: JANUS AUTOMATED WORKSTATION Product Codes: AJS4001, AJM4001, AJI4001, AJL4001, AJS8001, AJM8001, AJI8001, AJL8001, AJM4G01, AJI4G01, AJL4G01, AJM8G01, AJI8G01, AJL8G01, AJM4M01, AJI4M01, AJL4M01, AJM8M01, AJI8M01, AJL8M01 NGS EXPRESS Product Codes: AJS4NGS
Raisin Bagel with Cream Cheese wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy (oil), and Milk
Sausage, Egg and Cheese on Kaiser wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy(oil, lecithin) Milk
Chicken Salad on Kaiser Roll, 5 oz. Undeclared allergens - Wheat, Soy (oil, flour)
Regular Hoagie on Italian Roll, wrapped in clear film, 7 oz. Undeclared allergens - Wheat, Soy (oil), Milk
Cheeseburger wrapped in clear film, 5 oz. Undeclared Allergens - Wheat, Soy (Lecithin, oil, flour), Milk,
Hot Sausage on Club wrapped in clear film, 6 oz. Undeclared allergens - Wheat, Soy (oil)
Turkey Club on White wrapped in clear film, 4 oz. Undeclared allergens - Wheat, Soy (oil)
Imported Ham with Potato salad wrapped in clear film, 8 oz. Undeclared allergens - Wheat, Soy (oil), Milk, Egg
Bagel and Cream Cheese wrapped in clear film, 5. oz.
Roast Beef and Cheddar Cheese on Kaiser Roll wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy (oil, flour), Milk
Mild Italian Sausage on Italian Roll wrapped in clear film, 6 oz. Undeclared allergens - Wheat, Soy (oil, flour)
Meatball on an Italian Roll with Cole Slaw wrapped in clear film, 8 oz. Undeclared allergens - Wheat, Soy (oil, flour), Milk, Egg
Ham and Cheese on Club wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy (oil, lecithin), Milk
Hot Sicilian- Ham, Pepperoni and Provolone Cheese wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy( oil flour), Milk
1/4 1b. Hot Dog with Cheese wrapped in clear film, 6 oz. Undeclared allergens - Wheat, Soy(oil, lecithin) Milk
Salisbury Steak with Gravy on Kaiser with whipped potatoes wrapped in clear film, 8 oz. Undeclared allergens - Wheat, Soy (oil, flour), Milk
Bacon Egg and Cheese on Kaiser Roll wrapped in clear film, 5 oz. Undeclared allergen - Wheat, Soy (oil, lecithin), Milk, Egg
Turkey, Bacon and Swiss on Macaroni Salad wrapped in clear film, 8 oz. Undeclared allergens - Wheat, Soy (oil, flour), Milk, Egg
Vegetable and dip, 6 oz. Undeclared allergens - Soy( oil), Milk
Egg Salad on Wheat wrapped in clear film, 5 oz. Undeclared allergens - Wheat, Soy (oil) and eggs
MTR MASALA Sambar Powder, Net Quantity: 200g
Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02
Medi Choice Arm Slings ASL 2103 Small 7.5 x 12.5 Inch 1/EA, 24 ENCA ASL 2104 Medium 8 x 15 Inch 1/EA, 24 ENCA ASL 2105 Large 8.5 x 17.5 Inch 1/EA, 24 ENCA ASL 2106 Extra-Large 9 x 20 Inch 1/EA, 24 ENCA ASL 2150 Universal 7 x 18 Inch 1/EA, 24 ENCA Medical - An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.
Red Blood Cells, Leukocytes Reduced, Irradiated
Blood and Blood Products for Reprocessing
NORTHERN CLASSICS NATURAL SMOKED STEELHEAD*** Product is packaged in bulk 5lb case. Product is vacuum packaged catch weight.
***PREMIUM SMOKED SALMON***CRACKED PEPPER*** NET WT: 4OZ***Packaged 5 lbs case 20/4oz vacuum packages/case. Cardboard type label is folded over and affixed to the top of the package. Sell by date is marked on the label by the consignee. UPC 7 02772 00560 2.
WILD CATCH PREMIUM SMOKED SALMON***NATURAL***NET WT: 4OZ*** UPC 7 02772 00559 6. Cardboard type label is folded over and affixed to the top of the package. Sell by date is marked on the label by the consignee.
***NORTHERN CLASSICS NATURAL SMOKED SALMON. Net WT. is filled in on a separate white label. Product is frozen and vacuum packed. Product also referred to as SALMON HOT SMKD SIDE ATL SK-ON.
PREMIUM SMOKED SALMON***CAJUN***NET WT: 4OZ***Cardboard type label is folded over and affixed to the top of the package. Sell by date is marked on the label by the consignee. UPC 7 02772 00562 6.
PREMIUM SMOKED SALMON UPC 7 02772 00564 0 Packaged in a 5 lb case 20/4oz vacuum packaged per case. Cardboard type label is folded over and affixed to the top of the package. Sell by date is marked on the label by the consignee.
***NORTHERN CLASSICS FINEST QUALITY KIPPERED SALMON CHUNKLETS. This package can be combined with other products and placed into a combination package. Each package is individually labeled. Bulk cases contain 5 lbs.
DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum
Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures
Gammex Non-Latex Sensitive Neoprene Surgical Gloves Ansell Lanka (pvt) Ltd. Biyagama Export Processing Zone, Biyagama, Sri Lanka Ansell Healthcare Europe, N.V Internationaleiaan 55, 1070 Brussels, Belgium Manufactured for/ Fabrique' pour: Ansell Healthcare products LLC. 1635 Industrial Road Dothan, AL 36303, USA TEL USA- 1-800-952-9916 CAN- 1-844-494-7854 catalog #20277285
Ariels OM Grown Granola. Product number GR200, net wt. 5 lb., packaged in bulk bag inside plastic bucket. Product number GR201, net wt.15 lb., packaged in bulk bag inside plastic bucket. Product number BAG-GR200, net wt. 8 oz., packaged in cellophane bag with cardstock label. Product number SBAG-GR200, net wt. 4 oz., packaged in cellophane bag with cardstock label.
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.
SET UP PACK Surgical Instrument Tray, REF/Catalog No. 6250R1, STERILE, Rx Only --- busse Hospital Disposables Hauppauge, NY --- Device Listing # A343147
CARPAL TUNNEL PACK, Surgical Instrument Tray, REF/Catalog No. 3366, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # D190549.
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT TITANIUM RETAINING SCREW An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) PICK-UP IMPRESSION COPING An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT HEXED TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i LOW PROFILE ABUTMENT 4.1MM(D) X 3MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 4.1MM(D) X 2MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
x 11 silver and clear mylar ziplock bags that contain 500g of DMAA.
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
OTW PTA Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.
RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB10218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
OSCOR BREEZEWAY 10F S60.8CM D65.6CM FIRM TIP Catalog # AB1061FT Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
OSCOR ADELANTE BREEZWAY 8F STRAIGHT S79CM D84CM Catalog # AB081211 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
OSCOR ADELANTE BREEZEWAY 8F STRAIGHT S61CM D66CM Catalog # AB081210 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
OSCOR ADELANTE BREEZWAY 10F STRAIGHT S79CM D84CM Catalog # AB101219 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
OSCOR ADELANTE BREEZEWAY 10F STRAIGHT S61CM D66CM Catalog # AB101218 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture.
Toms of Maine Naturally Dry Natural Powder Antiperspirant Stick, Distributed by: Tom's of Maine, Kennebunk, ME 04043, Made in Canada, Unit UPC: 077326831953 Case UPC: 10077326831950
GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments
IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Siemens Material Number (SMN) 10706279 (US); Catalog Number LKPS1, SMN 10380960 and Catalog Number LKPS5, SMN 10380949 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.
IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2KPTS2, SMN 10706281 and REF/Catalog Number L2KPTS6, SMN 10706282 (US); REF/Catalog Number L2KPS2, SMN 10380986 and REF/Catalog Number L2KPS6, SMN 10380996 (OUS); IVD --- Origin: UK Siemens Healthcare Diagnostics Products Ltd. Llanberis, Gwynedd, LL554EL UK For in vitro diagnostic use with the IMMULITE /IMMULITE 1000/IMMULITE 2000/2000 XPi Analyzers for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. This assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.
Jalapeno Peppers, 40lbs (19 kg) per case, 1 1/9 Bushel Box, 49 cases per pallet
Rissois De Camarao Cong. Frozen Shrimp Cakes, Frozen 50 count. Net Weight: 4,50Kg (2 x 2,25Kg) Country of Origin: PORTUGAL
Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.
A head (C) connected to the shank (B) and removes material using machined flutes. The head is machined directly on the shank/neck of the bur.
Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48.
Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.
AQURE System Software Version 2.2.0 Model #: 933-599 UDI: (01)05700699335999(10)2.2.0 Catalog number: 933-599 The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple neurosurgical procedures in the near proximity of the MR scanner without a need to move the patient back to the OR suite
Preferred Meals, Cook and Serve, Creamy Red Pepper Sauce and Cheese Tortellini with Parmesan Cheese, 54 9.25 OZ units (NET WEIGHT 31.22 LBS) KEEP FROZEN INSTITUTIONAL USE ONLY
Preferred Meals, Cook and Serve, Cavatappi Pasta with Mascarpone Tomato Cream Sauce; 54 9.25 OZ units (NET WEIGHT 31.22 LBS) KEEP FROZEN INSTITUTIONAL USE ONLY
Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Number 10704-400; Savannah-T Straight Rod, 500mm; Savannah-T High Top Straight Rod, 200mm; Savannah-T High Top Straight Rod, 220mm, Part Number 1705-220; Savannah-T High Top Straight Rod, 240mm, Product Code 10705-240; Savannah-T Straight Rod, 260mm, Part Number 10705-260; Savannah-T Straight Rod, 280mm, Part Number 10705-280; Savannah-T Straight Rod, 300mm, Part Number 10705-300; Savannah-T Notched Curved Rod, 200mm, Part Number 10706-200; Savannah-T Curve Rod, 200mm, Part Number 10707-200 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
Blunt Non-Threaded Nitinol Guide Wire, Part Number 9080B-N-18U; Lodestar K-wire Non-Threaded, 18, Part Number 9080L-18U; 1.4mm x 18 Threaded Nitinol Guide Wire, Part Number 9080-N-18T; 1.4mm x 18 Non-Threaded Nitinol Guide Wire, Part Number 9080-N-18U The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
EnLite instrument. The test is indicated for use as an aid in screening newborns for severe combined immunodeficiency disorder (SCID). Product Number: 3401-001U
Streit's Quinoa with Mushrooms & Herbs, Net Wt. 7.7 oz (220g). Product of Israel
Black Widow Plate 19mm Plate, Part Number TBP119; Black Widow Plate 23mm Plate, Part Number TBP123 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, Part Number TBS030 The Black Widow Buttress Plates and Screws are designed for preventing migration or expulsion of allograft or autograft in the thoracolumbar to S1 Spinal region
Phil-Am Smoked Mackerel (Hasa Hasa) Net. Wt. 200g (7.05 oz.) packaged: Clear flexible plastic pouch and is topped by a predominantly red tag affixed to the top seal which has the products information.
Malayuguo, USA jiazhoufengwei, Fish, NET WT 4.2oz (120g)
Heihujiaoyupai, USA jiazhoufengwei, Fish, NET WT 4.2oz (120g)
Qiejidingxiangyu, USA jiazhoufengwei, Fish, NET WT 4.2oz (120g)
CyberKnife Robotic Radiosurgery Systems, models: G3, G4, VSI. Radiology: The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur bone
FAIRWAY LIKE NO OTHER MARKET brand CANDY CORN, of varying weight, Item Code 228402 XXXXXX -- The product is packaged in clear, plastic cello bags of varying weights, each weighing less than one pound. --- PACKAGED BY FAIRWAY MARKET 2284 12TH AVE., NEW YORK, NY 10027
CANNIBAL FEROX AMPED, FACE-MELTING NOOTROPIC, PRE-WORKOUT ENERGY COMPLEX, STRAWBLOODY KIWI CRUSH, DIETARY SUPPLEMENT, NET. WT. 9.9 OZ (280g), Chaos and Pain, UPC 1056331460
Merge OrthoCase software. The firm name on the label is Merge Healthcare, Hartland, WI.
Haemonetics El Dorado Donor Blood Establishment Computer Software (BECS)
White Fudge Oreo, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz. and 16 oz.
Plain Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12,16, and 24 oz.
Nutty fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12,16, and 24 oz.
Coconut Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz.
Dark Chocolate Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 16, and 24 oz.
Salted Caramel Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 16, and 24 oz.
White Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8 oz.
Peanut Butter Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12, and 16 oz.
Rocky Road Fudge, brand Real Fudge. Product is sold in clear plastic deli container in 8, 12, and 16 oz.
AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320-1799, U.S.A., NDC 76075-102-01
Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Storage: ROOM TEMP

Product Quantity
2449 Cases x 6 bags of 7.6 oz each = 14,694 of 7.6 oz bags.
576,802 cases total for product codes 7503, 7905, and 7526
Total volume made and distributed from 8/1/2016-11/2/2016: Chocolate Croissant 6pk: 7892 units.
Total volume made and distributed from 8/1/2016-11/2/2016: Plain Croissant 6pk: 42118 units.
Total volume made and distributed from 8/1/2016-11/2/2016: Multigrain Croissant 6pk: 1547 units.
4705 kits (US: 390 kits; OUS: 4315 kits)
6697 kits (US: 1646 kits; OUS: 5081 kits)
30 sites potentially have the effected versions
290/8 oz. units; 60/12 oz. units; 18/16 oz. units; and 5/24 oz. units
261/8 oz. units; 60/12 oz. units; 16/16 oz. units; and 11/24 oz. units
82/8 oz. units; 5/16 oz. units; and 2/24 oz.
73/8 oz. units; 4/16 oz. units; 3/24 oz. units
78/8 oz. units; 60/12 oz. units; and 7/16 oz. units
59/8 oz. units; 60/12 oz. units; and 7/16 oz. units

Reason for Recall
The firm is recalling Rx CHOICE brand LIQUID VITAMIN C because the active ingredient is at a lower level than stated on the label.
Due to concerns of re-fermentation, bottles may burst under increased pressure.
Arkray Factory is recalling Spotchem ll Glucose and Spotchem ll EZ Check Health Check Vet Multistrip [Panel-V] because the test strips are incorrectly reporting low blood glucose at levels above 265/dL..
Simply Fresh Fruit is recalling cantaloupe and fruit mixes with cantaloupe because they may be contaminated with Listeria monocytogenes.
Marketed without an approved NDA/ANDA - presence of undeclared sibutramine.
Marketed without an approved NDA/ANDA - presence of undeclared sildenafil.
Sunflower seeds purchased from SunOpta that are potentially contaminated with Listeria.
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
The condiment kits in some Caesar Salad bags contain undeclared allergens: tree nuts (walnuts).
raw frozen ground spent hen is recalled due to a potential contamination with Clostridium botulinum.
Mixed feed containing ground spent hen are recalled due to a potential contamination with Clostridium botulinum.
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Microbial Contamination of Non-Sterile Products: contamination with the bacteria, Burkholderia cepacia.
CGMP Deviations: potential contamination of products manufactured on the same equipment and lines as the contaminated product.
Non Sterility; contaminated with Klebsiella pneumoniae
The firm has recalled the product due to cladosporium (mold).
Presence of particulate matter: Confirmed customer report for the presence of particulate matter within a single vial.
Non-Sterility; microbial contamination identified as Bacillus circulans
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Products are not designed, qualified, manufactured, and/or managed under a state of control per internal quality system procedures and external laws, regulations, directives, standards, and/or guidance (such as 21 CFR 820 Quality System Regulation)
Labeling Defects: missing label, double label, missing lot/expiration, partial or illegible lot/expiration date. The same lots may contain bottles with possible foil seal defects (loose or incompletely sealed to the bottle).
The products were found to contain microbial contamination.
Defective delivery system: detached needles on the syringe in the kit.
Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets.
A single lot code of peanut butter used by the firm contained elevated aflatoxin levels
Non-Sterility: failed sterility test result.
Preliminary findings indicate that mixing procedures were not correctly followed leading to the possibility that lot 6222 might not be completely uniform
Product sterility is compromised due to breach of the sterile barrier
Products contain soy ingredients not declared on the label.
Products contain yellow#5 ingredients not declared on the label.
There is a potential presence of white plastic in the finished product.
Certain pints of Ben & Jerrys Brownie Batter Core Ice Cream may contain soft plastic pieces.
Greatbatch Medical the manufacturer of the 4F and 5F sheath/dilator components has determined that the products listed in their September 7, 2016 Recall Notification have the potential for the rotating luer to detach from the dilator hub during use. AngioDynamics has confirmed that affected sheath/dilators (Greatbatch Model Numbers 10904-001 and 10904-002) have been included in packaged AngioDynamics Stiffened Micro-Introducer Kits.
Several meals for dogs are recalled due to contamination with Listeria monocytogenes
Nuvectra is conducting a recall due to two clinical risks that are associated with certain percutaneous leads currently being used in the Algovita Spinal Cord Stimulation System. It has been reported that in some percutaneous leads, the stylet protruded beyond the distal lead tip.
Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating the Model 8870 software application card (to version AAU01) and the SynchroMed pump labeling to address the priming bolus issue.
Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Defective tips have the potential to pipette/dispense volumes 50-100% lower than is specified for the tips.
Crescent vending sandwiches failed to declare allergen ingredients: wheat, soy (oil) and milk.
The firm distributed a product prior to FDA release for an article which appears to contain Salmonella and was Subject to Import Alert #99-19
Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.
1, 2016 reported surface contamination on the arm slings. Two additional complaints reported on September 19, 2016 and October 7, 2016 reported the same issue. Upon receipt of the complaints on September 1, 2016, Owens & Minor immediately initiated a CAPA investigation for root cause analysis and determination of corrective/preventive actions. A quality inspection of inventory confirmed that the surface contamination was confined to lots manufactured in May, June, and July of 2016. The surface contamination for these lots was found to be frequent. Subsequent August product lots were inspected and no surface contamination was found. Limited inventory from lots prior to May 2016 were available and inspected as well. No surface contamination was found on these prior lots. Owens & Minor has quarantined the affected product lots. The product is on hold at all Owens & Minor Distribution Centers (DC). Samples of contaminated product have been sent to the manufacturer for evaluation and to a certified testing lab for identification of contaminate. These results are pending at this time. Based on the frequency of the product defect as well as evaluation of potential adverse health event risk, Owens & Minor initiated a voluntary recall for the above stated affected product lots.
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
CRP samples diluted using VITROS Chemistry Products Specialty Diluent, VITROS Chemistry Products FS Diluent Pack 3, or a sample with a low concentration of CRP had positively biased results if the endogenous level of CRP in the diluent is not subtracted from the final result. The IFUs do not provide specific instructions for how to account for endogenous CRP in the diluent when calculating the sample result. Orthos diluents used to dilute samples containing CRP are manufactured using human plasma based fluids that contain endogenous CRP. Without accounting for the CRP in the diluent and removing its contribution from the result, the reported result will include the CRP present in both the sample and diluent, possibly leading to positively biased results.
Northern Fish Products is recalling hot smoked salmon, black cod, steelhead, and trout, with the exception of hot jerky salmon and jerky salmon due to undeclared soy.
A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L.
Device could cause a patient overpressure situation without any visual or auditory indication or warning
Blood products, mislabeled as to antigen phenotype, were distributed.
Blood Product, collected from a donor who disclosed receiving a vaccine within eight weeks of donating, was distributed.
Ansell Healthcare Products is initiating a voluntary recall involving 15 cases of Gammex Non Latex Sensitive Surgical Gloves because the packaged contents incorrectly included a natural rubber Latex surgical glove.
Ariels Om Grown Granola is recalled because it was contaminated with wheat seed.
Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
Smiths Medical became aware that three (3) lots of Acuvance2 Safety Catheter, product number 1720-AI, contain devices with missing or incorrectly positioned side port valves.
Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.
Labeled as a 48mm Cortical Screw but measuring at 50mm
A limited number of product pouches may not have been sealed during packaging.
Naturecom dba NutriVitaShop is recalling DMAA net weight 500 g because there may be presence of 1,3-dimethylamylamine.
Failed Dissolution Specifications; 6 month time point
Platelet products, which failed leukoreduction quality control, were distributed.
.018 Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter. During an unrelated manufacturing inspection of scrapped products, an out of specification condition was observed. The catheter outer shafts were pinched and deformed at the proximal balloon bond. Bench testing of affected devices showed that this resulted in either the inability to inflate the device, a slow deflation, or the inability to deflate the device post expansion.
Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.
Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
Labeling: Label Mix Up- Incorrect back label applied to the product.
A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.
AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.
Siemens Healthcare Diagnostics has confirmed that the IMMULITE/ IMMULITE 1000 Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.
Siemens Healthcare Diagnostics confirmed that the IMMULITE 2000/ IMMULITE 2000 XPi Systems PSA assays are not meeting the current High-dose Hook Effect expectation in the Instructions for Use.
Coliman Pacific Corp is recalling Jalapeno Peppers because they may be contaminated with Salmonella.
The product is an acidified food without a registered manufacturer and scheduled process
Failure to declare ingredients in English: allergens (soy, sulfite, yellow #5, and MSG ) and unpermitted food color E124 - Ponceau 4R
Incorrect priming volume is printed on the device package.
Stryker Instruments is voluntarily recalling specific lots of sterile MIS Toolsteel Burs because the burs may exhibit signs of corrosion.
The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.
Lack of Assurance of Sterility: confirmed customer complaints of leaking bags.
Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
Possibility that a patient or user may be exposed to a very small level of touch current.
Possible contamination of product with Listeria monocytogenes.
Labeling error where three boxes in inventory had conflicting patient and primary labels. Evaluation indicated that the primary label and patient label did not match. The primary label matched the label on the inner pouch, but the patient label was incorrect.
Complaints that the tip of the awl broke after impaction during surgery.
The rods are packaged in packages with unacceptable seals. In some cases, the integrity of the seal is compromised by channels or voids.
Unique Device Identifier (UDI) is missing from outer kit box label.
The Commonwealth of Virginia sampled the product and revealed the presence of undeclared sulfites at 57 ppm and 10 ppm
Platelet product, for which quality control testing did not meet specifications, was distributed.
Platelet component, for which product QC was unacceptable, was distributed.
There is a problem with the mating feature between the plate and screw which could cause the plate opening not to interfere enough with the plate and head of the screw.
Phil-am Trading, Inc. is recalling Phil-am Smoked Mackerel (Hasa-Hasa), because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening illness or death.
Blood products, for which donor screening was performed incorrectly, were distributed.
The product is a low acid canned food (LACF) without a registered manufacturer and scheduled process.
collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid.
The recalling firm has received 5 customer inquiries reporting that at least one pouch of the double pouch packaging configuration has been punctured by the tip of the device's stem.
Product was analyzed and found to contain 1,3- dimethylbutylamine which was not declared on the label and is a prohibited substance.
Measurements in the software are changing after saving a plan with a measurement result, which may result in potential patient injury or delay in diagnosis or treatment.
Blood bank software, with a defect or glitch, was distributed.
Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed.
White Fudge Oreo is recalled due to undeclared wheat and blue # 1.
Plain Fudge is recalled due to undeclared blue #1.
Nutty fudge is recalled due to undeclared blue #1.
Coconut Fudge is recalled due to undeclared blue #1.
Dark Chocolate Fudge is recalled due to undeclared blue #1.
Salted Caramel Fudge is recalled due to undeclared blue #1.
White Fudge is recalled due to undeclared blue #1.
Peanut Butter Fudge is recalled due to undeclared blue #1.
Rocky Road Fudge is recalled due to undeclared blue #1.
Blood products, not tested according to specifications, were distributed.
Blood product collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood product, in which donor suitability was not adequately determined, was distributed.
Lack of Assurance of Sterility: Potential cracks in glass vials

Code Info
PL4L91 PL4M92 PL5A93 PL5B94 PL5C96 PL5E98 PL5G01 PL5H02
Firm's product code N34B lot code L902095
All lots with Use by Date of 5/22/2016 to 8/31/2016
ALL serial numbers and lot numbers sold since January 14, 2003.
ALL serial numbers and lot numbers sold since 2003.
Lot #: 30051601, 30051602*, 30051603, 30051604, Exp Jan-18, *some bottles contain the incorrect expiration date of Jan-28.
12 pack Gourmet Salted Caramel Chocolate Chunk Cookies Net Wt.15 oz.UPC 289785003998; 24 pack Gourmet Chocolate Chunk Salted Caramel Cookies- Net Wt. 30 oz UPC 28977606991 8/14/2016; 12 pack Gourmet Salted Caramel Chocolate Chunk Cookies Net Wt.15 oz. UPC 289785020399; 24 pack Gourmet Chocolate Chunk Salted Caramel Cookies- Net Wt. 30 oz. UPC 289776706990 28/29/16
Kid's Rainbow Sprinkled Cookie Platter 4 lb 14 oz UPC 269935316994 08/30/16
12PK Gourmet Variety Pack Cookies 15 Oz.. UPC 289786203991 8/29/16 24 pack Variety Cookies Net Wt. 24 oz. UPC 208726004191 8/30/16
Dipped Chocolate Chip Cookies Net Wt. 24 oz UPC 269954004995 08/30/16
Gourmet Chocolate Dipped Cookies Net Wt. 46 oz UPC 269969414994 08/30/16
12 pack Gourmet Oatmeal Raisin Cookies Net Wt 15 oz. UPC 289784203993 08/29/16 24 pack Gourmet Oatmeal Raisin Cookies Net Wt. 30 oz. UPC 289774706992 Gourmet Oatmeal/Raisin Cookies Net Wt. 30 oz UPC 289771006996 08/29/16
Lots beginning with: P4J, P4K, P4L, P4M, P5A, P5B, P5C, P5D, P5E, P5F, P5G, P5H, P5J, P5K, P5L, P5M, P6A, P6B, P6C, P6D and lots P6E0016GX,P6E0049GX, , P6E0050GX, P6E0051GX, P6E0052GX, P6E0163GX, P6E0164GX, P6E0212GX
All product on market, any best by date prior to 9/21/2018.
All product on market, any best by date prior to 9/30/2017
All product on market, any best by date prior to 9/30/2018
All product on market, any best by date prior to 9/21/2018
Lot # 3142070, manufacturing date: 7/20/16.
Lot # 3155070; manufacturing date 7/25/16.
Lot # 3146070, manufacturing date: 7/21/16.
software application cards with versions other than AAU01
Product Code: MAD800, Lot# 160208 and 160625 and Product Code: MAD900, Lot# 160605.
UPC Code Product Desc Lot Code 0248422008994 CROISSANT CHOCOLATE 6 PK sell by 11/5 and before
UPC Code Product Desc Lot Code 0248421006991 CROISSANT 6 PK. sell by 11/4/16 and before
UPC Code Product Desc Lot Code 0241654006998 MULTIGRAIN CROISSANT 6PK sell by 11/4/16 and before
Affected Generations (GENs): 3, 11, 12, 30 through 36
5lb and 15lb bulk containers have a manufacturing date (mm/dd/yy) stamped on label or bucket: 070315 through 100616, or a Julian date of 16294 through 16331. 4 oz and 8 oz packages have a Julian code of 15184 through 16331.
Lot Number 1230323, Exp. Date December 2016; Lot Number 1230387, Exp. Date December 2016; Lot Number 1231616, Exp. Date December 2016
Lot Number 1530330, Exp. Date November 2017; Lot Number 1530241, Exp. Date September 2017; Lot Number 1530095, Exp. Date September 2017; Lot Number 1431734, Exp. Date August 2017; Lot Number 1431066, Exp. Date May 2017
Lot Number 1230783, Exp. Date February 2017; Lot Number 1330825, Exp. Date April 2018
Product Number: 10-1500-3048 Lot Number: 161421-G
All lots LKPS1/LKPS5 - Lots 443, 445, 446 LKPTS1 - Lot D116
All lots L2KPS2/L2KPS6 - Lots 408, 409, 410 L2KPTS2/L2KPTS6 - Lots D112, D123, D124
Catalog ID (part # 60.119.012), Lot Number FL00528
Lot #: P344028 on bags, P344028A on shipping container, Exp 12/31/2017
Part Number 1-110926B - Lot Number 128945 and Part Number 1-120922B - Lot Number 128946
Part Number 139005 - Lot Number 182-16146
distribution dates -February and November 2016; no codes on product
SurePath Collection Vial Replacement Cap, cat no. 490505 SurePath GYN Preservative Vial Kit, cat no. 490527 SurePath GYN Preservative Vial Kit with Cervex-Brush, cat no. 491095 SurePath GYN Preservative Vial Kit with Cervex-Brush Combi, cat no. 491096 SurePath GYN Preservative Vial Kit with Brush/Spatula, cat no. 491097